- The National Evaluation System for health Technology Coordinating Center (NESTcc) on Wednesday published a pair of documents on best practices when collecting and using real-world evidence for medical device research.
- The Data Quality Framework addresses research using data from clinical care electronic health records, pharmacies, public and private claims, registries, and patient-generated data, while the Methods Framework is intended to highlight device-specific considerations, including understanding of a targeted disease, device risk, indicated population, patient selection, device description, monitoring plans and more.
- The frameworks aren't set in stone; NESTcc said they will be updated going forward based on lessons from the organization's test cases, RWE projects evaluating either pre- or postmarket medical devices with the help of research collaborators.
Generation of real-world evidence has grown in recent years, in some cases as an alternative to clinical studies as a means to assess medical device safety and performance, particularly in the postmarket setting. Increased scrutiny on the medical device approval process, in part spurred by safety controversies uncovered once a product hit the market, has also driven momentum.
NESTcc, formed by FDA and the Medical Device Innovation Consortium in 2016, set out to offer guidelines on best practices for research. MDIC is itself a joint FDA-medical device industry partnership, with heavy hitter execs from J&J and GE on its board.
NESTcc established subcommittees of experts from FDA, health systems and academic institutions to consider recommendations medtech stakeholders might need regarding data quality and methods. Some members of those teams had past experience with surveillance infrastructure including the National Patient-Centered Clinical Research Network (PCORnet), the Medical Device Epidemiology Network Initiative (MDEpiNet), and FDA’s Sentinel Initiative.
The frameworks’ objectives are to “explore the feasibility for medical device ecosystem stakeholders to work with RWD sources” and NESTcc’s Network Collaborators, and identify areas where NESTcc could play a role in reducing transaction costs.
Work on the frameworks began in the 2018, when each of the subcommittees were formed, and during monthly meetings began developing framework documents. The draft versions of the two framework documents were provided to those network collaborators for review and comment, which were then incorporated into the versions released this week.
Currently, government funding for NESTcc is set to run through 2022, meaning much of NESTcc's future depends on buy-in from industry.